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Journal of Regulatory Compliance

New Rules for Illinois Firearms Dealers

The Firearms Dealers License Certification Act (also known as the Combating Illegal Gun Trafficking Act) was signed into law on January 18, 2019 and requires all Federal Firearms License (FFL) dealers engaged in the business of transferring firearms to have their FFL certified by the Illinois State Police. Nevertheless, many areas of the regulations remain in dispute and strong opposition has led to the delay of dates for required compliance. The Act is also being challenged by the Illinois State Rifle Association and a number of gun dealers in Illinois who deem that the Act is an unconstitutional infringement on their right to keep and bear arms.

COVID-19 Break in Regulation of Waivers for State Medicaid Agencies

COVID-19 was an unexpected pandemic that hit the United States, causing Centers for Medicare and Medicaid Services (“CMS”) to rush to make accommodations for the states. States administer their Medicaid programs following a state plan and under the regulation of federal rules. With approval, states are allowed to amend their state plan and apply for waivers to improve the effectiveness of their Medicaid program. During COVID-19, the Trump Administration made available for states to apply for 1115 waivers, creating a new section labeling 1115(a), the 1135 waiver, and Appendix K to amend 1915(c) waivers for national emergencies. As of May 2020, CMS reported over 200 approved waivers across multiple states.

Telehealth in the Age of COVID-19

The Health Insurance Portability and Accountability Act – enacted in 1996 by the U.S. Congress and signed by then-President Bill Clinton – has long served to maintain the standards of electronic health records and patient privacy, among many other provisions. Violating HIPAA can result in both criminal prosecution as well as steep civil penalties. As the healthcare industry transitioned from the use of paper records to storing patient data on electronic health records over the last two decades, health organizations have learned to adapt to HIPAA compliance, with many increasing their compliance programs by hiring full-time compliance officers, designating an individual as the compliance manager, and/or appointing a compliance committee within the organization.

The Regulation of Meat and Poultry Processing Facilities in COVID-19

The meat and poultry packing industry has recently fallen victim to the spread of COVID-19. Among fierce backlash over the federal government’s lack of action to protect meat packing facility workers, the CDC and OSHA released interim guidelines. These guidelines are to be followed by employers not only to keep workers safe, but to avoid a shortage of one of America’s most prized food sources: meat and poultry. The meat packing industry, as one of the most heavily-regulated industries in the United States, now faces increased regulation during a global pandemic.

Employer Compliance with CARES Act

On March 27, 2020, President Donald J. Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (H.R. 748), otherwise known as the “CARES” Act. Originally introduced in January as the Middle-Class Health Benefits Tax Repeal Act, the bill was then revised to address the needs of the United States amid the coronavirus pandemic. The bi-partisan CARES Act, with strong support from the White House, ultimately passed the House of Representatives with a 419-6 roll call and the Senate with 96-0 votes.

Telehealth Services Amid a Global Pandemic

With COVID-19 rapidly spreading, telehealth services have been seeing an explosion of demand. On March 17, 2020, President Trump announced during a White House press briefing an unprecedented expansion of telehealth services for the 62 million Medicare beneficiaries who are amongst the most vulnerable to the disease. The Department of Health and Human Services (“HHS”) and Centers for Medicare and Medicaid Services (“CMS”) have since vowed to work with the administration by temporarily relaxing certain HIPAA, altering licensure, cost-sharing, and auditing requirements. As the number of patients increases, compliance and privacy risks associated with telehealth also surge.

Tiger King and Zoo Auditing

Libby Meadows Associate Editor Loyola University Chicago School of Law, JD 2021 Like many people during this quarantine, the majority of my days are spent switching through different streaming sites trying to find anything entertaining to watch. Towards the end of March Tiger King: Murder, Mayhem and Madness was released on Netflix. It instantly took …
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Prescribing Online with COVID-19

COVID-19 has rapidly changed the healthcare field unlike anything has before. With the continued spread, healthcare providers have started to adopt telehealth as a way to access patients and continue to provide quality care, without breaking their self-isolation. One avenue that has long been closed off for physicians has been online prescribing, but COVID-19 appears to be changing even that.

Action Against Individuals Regarding Fraudulent Genetic Testing

Michael Manganelli Associate Editor Loyola University Chicago School of Law, JD 2021 In October 2019, The Department of Justice (“DOJ”) announced a multi-agency and multi-state coordinated law enforcement action against 35 individuals involved in an alleged $2.1 billion genetic cancer testing scheme. The alleged scheme involved the payment of illegal kickbacks and bribes to medical professionals …
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Revamping America’s Organ Transplant System

 In December of 2019, two new rules were proposed by the federal government to increase the number of organ transplants in the United States. As of July 2019, 113,000 Americans sat on the national transplant waiting list. The first proposed rule would change the way Organ Procurement Organizations (“OPO”) report data on the number of organs procured. The second proposed rule creates new legislation to assist living donors after their transplant procedures. Both rules were proposed by the Health and Human Services Department (“HHS”) as a follow up to President Trump’s Executive Order on Advancing American Kidney Health.